Glycemic Response in Persons With Type 2 Diabetes Mellitus

Plasma Glucose and Insulin Response to Six Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus

This will be a randomized crossover design. The subjects will be randomized to one of six interventions on six separate study days, one week apart.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Oral Nutrition Supplement

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Tustin, California, United States, 92780
      • Orange County Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Subject inclusion criteria

All subjects must comply with all the following inclusion criteria:

• Age 20-75 years
• Type 2 diabetes controlled with diet or diet and metformin (Glucophage)
• Hemoglobin A1C less than 9.0%
• Fasting blood glucose less than 180 mg
• Hematocrit levels within normal limits
• Having obtained his/her informed consent

Subject exclusion criteria Subjects representing one or more of the following criteria are excluded from participation in the study.

• Abnormal thyroid function
• Creatinine >2.0 mg/dl
• Potassium <3.5 mEq/l
• Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
• Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
• Unable to give informed consent or follow instructions
• Current insulin therapy or insulin therapy within the past month
• Patient who are pregnant
• Allergies to milk, soy or any component of the test product
• Patient who in the investigators assessment cannot be expected to comply with treatment
• Currently participating or having participated in another clinical trial
• Patients with anemia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oral Nutrition Supplement A; Product containing calories from carbohydrate, protein, and fat	Other: Oral Nutrition Supplement; Product intake of oral nutrition supplement provided
Active Comparator: Oral Nutrition Supplement B; Product containing calories from carbohydrate, protein, and fat	Other: Oral Nutrition Supplement; Product intake of oral nutrition supplement provided
Active Comparator: Oral Nutrition Supplement C; Product containing calories from carbohydrate, protein, and fat	Other: Oral Nutrition Supplement; Product intake of oral nutrition supplement provided
Active Comparator: Oral Nutrition Supplement D; Product containing calories from carbohydrate, protein, and fat	Other: Oral Nutrition Supplement; Product intake of oral nutrition supplement provided
Active Comparator: Oral Nutrition Supplement E; Product containing calories from carbohydrate, protein, and fat	Other: Oral Nutrition Supplement; Product intake of oral nutrition supplement provided
Active Comparator: Oral Nutrition Supplement F; Product containing calories from carbohydrate, protein, and fat	Other: Oral Nutrition Supplement; Product intake of oral nutrition supplement provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the blood glucose curve (ACU 0-240 minutes)	Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the insulin curves (AUC 0-240)	Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Insulinogenic index [Change in Ins30/Change in Glu30]	[Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Joel Neutel, MD, Orange County Research Center

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2018
• Primary Completion (Actual): April 18, 2018
• Study Completion (Actual): April 18, 2018

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: 17.11.US.HCN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No